Comparing surgery alone to surgery with low-dose radiotherapy for early-stage nasopharyngeal cancer

Endoscopic Nasopharyngectomy Combined with Retropharyngeal Lymph Node Dissection Plus Low-dose Radiotherapy Versus Bilateral Upper Neck Dissection for Newly Diagnosed Stage I Nasopharyngeal Carcinoma: a Randomized Controlled Clinical Trial

This study is testing whether adding low-dose radiotherapy to surgery can help people with early-stage nasopharyngeal cancer live longer and have fewer side effects compared to surgery alone.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 86 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Sun Yat-sen University (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 2 sites (Guangzhou, Guangdong and 1 other locations)
• Trial ID: NCT06688760 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness and safety of two surgical approaches for newly diagnosed stage I nasopharyngeal carcinoma. Participants will undergo endoscopic nasopharyngectomy combined with either retropharyngeal lymph node dissection and low-dose radiotherapy or bilateral upper neck lymph node dissection. The study seeks to determine if the surgical approach can achieve similar survival outcomes to conventional radiotherapy while minimizing adverse effects. The trial will include patients with non-keratinized carcinoma who meet specific eligibility criteria.

Who should consider this trial

Good fit: Ideal candidates for this study are patients diagnosed with stage I nasopharyngeal carcinoma who have a performance status score of 0-1 and meet specific organ function criteria.

Not a fit: Patients with recurrent or metastatic nasopharyngeal carcinoma or those with severe organ dysfunction may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a less harmful treatment option for patients with early-stage nasopharyngeal carcinoma, potentially improving their quality of life.

How similar studies have performed: Previous studies have shown promising results with similar surgical approaches, indicating potential for success in this trial.

Eligibility criteria

Inclusion Criteria:

Inclusion Criteria:

* Performance Status Score 0-1 points.
* Non-keratinized carcinoma of the nasopharynx (differentiated or undifferentiated, i.e., WHO type II or III) confirmed histologically and/or cytologically.
* According to the UICC/AJCC eighth edition staging, the patient is defined as T1N0M0 stage I.
* Adequate organ function: WBC ≥ 4×10\^9 /L, NEUT ≥ 2×10\^6 /L, HGB ≥ 9 g/dL, PLT count ≥ 100×10\^9/L, TBIL ≤1.5 ULN, ALT ≤3 ULN, AST ≤3 ULN, ALP ≤3 ULN, ALB ≥ 3 g/dL, INR or APTT≤1.5 ULN, Scr ≤1.5 ULN or Ccr ≥ 60 mL/min.
* Informed Concent signed with willingness to obey the follow-up, treatment, examination and any other programs according to the research protocol.

Exclusion Criteria:

* Diagnosed as recurrent or distant metastatic nasopharyngeal carcinoma or together with any other malignancy.
* Suffering severe organ dysfunction or physical disorder which could not tolerate surgery or radiotherapy.
* Unable to cooperate with regular follow-up due to psychological, social, domestic or geological reasons.
* During pregnancy or lactation.
* Other patients that the chief physician considered as illegal for this trial.

Where this trial is running

Guangzhou, Guangdong and 1 other locations

• The Fifth Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (Recruiting)
• The Fifth Affiliated Hospital of Sun Yat-sen University — Zhuhai, Guangdong, China (Recruiting)

Study contacts

• Principal investigator: Ming-Yuan Chen, MD,PhD — SUN yet-sen University
• Study coordinator: Ming-Yuan Chen, MD,PhD

Conditions Nasopharyngeal Carcinoma; Surgery; Radiotherapy